NCT00529165已完成不适用
The Necessity of an Injection-Meal-Interval in Patients With Type 2 Diabetes Mellitus and Therapy With Human Insulin
University of Jena2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
The purpose of the study is to demonstrate, that there is no difference in metabolic control in patients with type 2 diabetes mellitus and therapy with human insulin with or without injection-meal-interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •Aged 40 - 80 years
- •Therapy with human insulin
排除标准
- •Pregnancy
- •Nutrition disorders
- •Psychological disease
- •Body Mass Index (BMI) less than 25 kg/m^2
- •HbA1c greater than 9%
结局指标
主要结局
HbA1c
时间窗: Week 16 and 28
次要结局
- Hypoglycemia(Week 16 and 28)
- Treatment satisfaction(week 16 and 28)
- Quality of Life(week 16 and 28)
研究者
研究点 (2)
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